TEG 6s viscoelastic testing

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We are implementing TEG6s at 2 of our hospital sites, and I have some questions. For those who do viscoelastic testing, is it done in the lab or at POC? For those doing it at POC, who is performing the test? My understanding is that the device is not FDA-approved for peds patients, but Haemonetics is telling us that it's used all over the country for peds patients, but not how the regulatory agencies are accepting this off-label use.
I also have some questions about how it is being billed, so if anyone has any experience with this I'd appreciate any information you have.
Thanks in advance for any help you can give. You can also email me at kathleen.david@tricore.org if you would like.

5 Replies

Peggy Mann

Thu Jan 20, 2022 at 8:07AM

Hi Kathleen, not sure if you are asking only as related to implementing the TEG6s?
Our viscoelastic testing is done in a 'POC lab' (some would consider it a 'satellite' type situation since it's a room adjacent to the liver transplant OR, glass window).
CLS Point of Care Coordinators in the POC Program work that service including as on-call rotation. Plus anesthesiologist unless that recently changed.
If you email me specifically about viscoelastic testing billing in an email, I can run with that issue to see if I can help but I don't usually have billing info in my wheel house (and glad of that!).

Jeremy MacDonald

Thu Jan 20, 2022 at 10:38AM

We do Teg 6s testing as POC and lab.

The Adult CVOR perfusionists perform the test in their dept during procedures.
The Peds CVOR wants this testing but due to it being considered off label it can only be performed by a MD or a Med Tech. So this testing has been setup to be performed in the lab. We are still waiting on the dept to submit to the lab the samples we will need to validate the peds reference range.

Kathleen David

Thu Jan 20, 2022 at 12:01PM

Thanks for the replies. I'm not sure how this is going to end up, but it's helpful to have input from others using the test.

Danyel Olson

Thu Jan 20, 2022 at 1:21PM

We have TEG in our main laboratory used on pediatric patients. It is run by lab staff. I asked my heme technical specialist and he didn't seem to think that it was specifically called out that it's not FDA approved for peds. Where is this stated?

Jeremy MacDonald

Thu Jan 20, 2022 at 3:29PM

Danyel,

See Haemonetics manufacturer user manual: 115191-US(AD) TEG 6s User Manual pg 11; "Intended Use"
"The TEG 6s System is indicated for use with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the TEG 6s System is used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions."

If specifically asked, the vendor will confirm this as well or at least my Rep did.

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TEG 6s viscoelastic testing